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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter Summaries of opinion Remove Summaries of opinion filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Withdrawn applications Remove Withdrawn applications filter

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Human medicine European public assessment report (EPAR): Ryeqo (updated)

relugolix, norethisterone acetate, estradiol hemihydrate, Leiomyoma
Date of authorisation: 16/07/2021, , Revision: 6, Authorised, Last updated: 04/12/2023
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Human medicine European public assessment report (EPAR): Yesafili (updated)

aflibercept, Macular Edema; Retinal Vein Occlusion; Diabetic Retinopathy; Myopia, Degenerative; Diabetes Complications
Date of authorisation: 15/09/2023, , , Revision: 1, Authorised, Last updated: 04/12/2023
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Human medicine European public assessment report (EPAR): Leflunomide medac (updated)

leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010, , Revision: 19, Authorised, Last updated: 04/12/2023
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Human medicine European public assessment report (EPAR): Filgrastim Hexal (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009, , Revision: 24, Authorised, Last updated: 04/12/2023
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018, , Revision: 9, Authorised, Last updated: 04/12/2023
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Human medicine European public assessment report (EPAR): Clopidogrel Krka (updated)

clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 23/09/2009, , Revision: 19, Authorised, Last updated: 04/12/2023
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Human medicine European public assessment report (EPAR): Fulphila (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018, , Revision: 12, Authorised, Last updated: 04/12/2023
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Human medicine European public assessment report (EPAR): Semglee (updated)

insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018, , Revision: 10, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Ogivri (updated)

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 12/12/2018, , Revision: 11, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)

insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021, , , Revision: 4, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Hulio (updated)

adalimumab, Hidradenitis Suppurativa; Psoriasis; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic
Date of authorisation: 17/09/2018, , Revision: 16, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)

Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020, , , Revision: 9, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Ocaliva (updated)

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 17, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Rubraca (updated)

rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018, , , Revision: 15, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Kalydeco (updated)

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , Revision: 38, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Inaqovi (updated)

cedazuridine, decitabine, Leukemia, Myeloid
Date of authorisation: 15/09/2023, , Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Yuflyma (updated)

adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 11/02/2021, , Revision: 12, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Soliris (updated)

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007, , , Revision: 36, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Abevmy (updated)

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 21/04/2021, , , Revision: 7, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Evusheld (updated)

tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022, , Revision: 6, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Pylclari (updated)

Piflufolastat (18F), Prostatic Neoplasms
Date of authorisation: 24/07/2023, , Revision: 1, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Enhertu (updated)

trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021, , , Revision: 13, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Nuceiva (updated)

Botulinum toxin type A, Skin Aging
Date of authorisation: 27/09/2019, , Revision: 5, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Riximyo (updated)

rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017, , Revision: 14, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Blitzima (updated)

rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017, , Revision: 19, Authorised, Last updated: 29/11/2023